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The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution
- 08806094940763 ()
- Self-care monitoring/reporting software
The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution
- 08806094940756 ()
- Self-care monitoring/reporting software
Rapid System Update
Ischemaview, Inc.
5.101
In Commercial Distribution
- B761R51011 ()
- Radiological PACS software
Assisted Care 24-Hour Oral Care Kit with Suction Tools (Mexico)
Avanos Medical, Inc.
47448
In Commercial Distribution
- 30680651474484 ()
- 20680651474487 ()
970600
- Oral care kit, single-use
No Description
Novocure GmbH
NovoTAL Software
In Commercial Distribution
- 07290107981729 ()
90094
- Alternating electric field antimitotic cancer treatment system generator
No Description
Novocure GmbH
NovoTAL Software
Not in Commercial Distribution
- 07290107981576 ()
90094
- Alternating electric field antimitotic cancer treatment system generator
No Description
Novocure GmbH
NovoTAL Software
Not in Commercial Distribution
- 07290107980715 ()
90094
- Alternating electric field antimitotic cancer treatment system generator
No Description
BIO-VIEW LTD
Solo Software
In Commercial Distribution
- 07290107653053 ()
- Fluorescence light microscope
No Description
Heidelberg Engineering GmbH
Software V7.0-US
In Commercial Distribution
- 04059237000815 ()
- Scanning-laser retinal imaging system
- Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
Software 6.12_US
In Commercial Distribution
- 04059237000570 ()
- Ophthalmic spectral-domain optical coherence tomography system
- Scanning-laser retinal imaging system